Celestoderm®-B with Garamicin® (Celestoderm®-V with garamycin®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspcream for external use
Composition:

1 g of cream contains:

active ingredients: betamethasone 17-valerate 1.22 mg (equivalent to 1.0 mg betamethasone), gentamicin sulfate (equivalent to 1.0 mg (1000 ME) gentamycin);

Excipients: paraffin white soft 150.0 mg, cetostearyl alcohol 72.0 mg, paraffin liquid 60.0 mg, macrogol-cetostearyl ether 22.5 mg, (phosphoric acid 0.02 mg, sodium dide and hydrophosphate dihydrate 3.39 mg (equivalent to 3.0 mg sodium dihydrogen phosphate monohydrate), chlorocresol 1.0 mg, sodium hydroxide and phosphoric acid (until pH is established), purified water q, s, up to 1.0 g.

Description:

Homogeneous cream of white color of soft consistency, not containing extraneous inclusions.

Pharmacotherapeutic group:glucocorticosteroid for topical use + antibiotic-aminoglycoside
ATX: & nbsp
  • Betamethasone in combination with antibiotics
    • Pharmacodynamics:

    Cream Celestoderm®-B with Garamycin® contains a glucocorticosteroid (GCS) betamethasone valerate, which has an anti-inflammatory, antipruritic and vasoconstrictive effect, and an antibiotic gentamicin, which has antibacterial activity of a wide spectrum of action. The number of susceptible gentamicin bacteria include sensitive strains Staphylococcus aureus (coagulase-positive, coagulase-negative and some penicillinase-producing strains), as well as gram-negative bacteria Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris and Klebsiella pneumoniae.

    Indications:

    Local treatment of skin diseases susceptible to GCS therapy in the presence of secondary infection caused by susceptible to gentamicin microorganisms, or suspected of such infection:

    - eczema (atopic, pediatric, coin-like), contact dermatitis, seborrheic dermatitis, neurodermatitis, sun dermatitis, exfoliative dermatitis, radiation dermatitis, diaper rash, psoriasis, anogenital and senile itching.

    The cream is used for diseases of moist or oily skin.

    Contraindications:

    - Hypersensitivity to any of the components of the drug;

    - tuberculosis of the skin, skin manifestations of syphilis, chickenpox, herpes simplex, fungal skin diseases;

    - the vaccination period and skin post-vaccination reactions;

    - lactation period;

    - pregnancy (prolonged treatment of extensive skin areas);

    - Children under 6 months.
    Carefully:

    - BVariability (in the absence of criteria for contraindication), especially in the first trimester;

    - long-term treatment of large areas of the skin, especially in children, or in the presence of skin cracks or the use of occlusive dressings.

    Dosing and Administration:

    Outwardly.

    Apply cream thin layer on the affected skin 2 times a day - morning and evening.

    Required frequency of application must establish a doctor, focusing on the severity of the disease. In mild cases, application once a day is usually sufficient, with more severe lesions, more frequent use may be required. The duration of treatment depends on the degree of severity, localization of the lesion, and the patient's response to treatment.

    Side effects:

    When using Celestoderm®-B cream with Garamycin®, hypersensitivity reactions, rashes and skin pigmentation disorders occur.

    The following are possible local reactions due to the use of betamethasone, especially when using occlusive dressings: irritation of the skin (itching, erythema), burning sensation, dry skin, folliculitis, hypertrichosis, steroid acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, striae, sweating.

    In the treatment of gentamicin there is a transient skin irritation (erythema, pruritus), usually not requiring withdrawal of treatment.

    With prolonged treatment or application to a large surface it is possible to develop systemic side effects characteristic of GCS: weight gain, osteoporosis, increased blood pressure, swelling, ulceration of the mucosa gastrointestinal tract, exacerbation of hidden foci of infection, hyperglycemia, agitation, insomnia, menstrual cycle disorders.

    In children, Besides, the following side effects can be noted, caused by the use of betamethasone: function suppression hypothalamic-pituitary-adrenal system, Itenko-Cushing syndrome, growth retardation, lag in the increase body weight, increased intracranial pressure. Symptoms of suppression of adrenal cortex function in children include a decrease concentrations cortisol in plasma and lack of response to stimulation adrenocorticotropic hormone (ACTH). Increase in intracranial pressure is manifested by bulging fontanel, headache, bilateral edema of the optic disc.

    Overdose:

    Symptoms. Excessive or prolonged use of local GCS or use in doses exceeding the recommended levels can cause oppression of the pituitary-adrenal system, which can lead to secondary adrenocortical insufficiency and the appearance of symptoms of hypercortisy, including Itenko-Cushing syndrome.

    A single overdose of gentamicin is not accompanied by the appearance of any symptoms. Long-term use or application in doses exceeding the recommended, can lead to a significant increase in insensitive microflora, including fungal, in the lesion focus.

    Treatment. The corresponding symptomatic treatment was shown. Acute symptoms of hypercorticoidism are usually reversible. If necessary, correction of electrolyte imbalance is shown. In the case of chronic toxic effects, gradual cancellation of GCS is recommended. With uncontrolled growth insensitive microorganisms or the development of fungal infection should stop treatment and choose appropriate therapy.

    Interaction:

    Any interaction of the drug Celestoderm®-B with Garamicin® with other medicines not registered.

    Special instructions:

    In the absence of the effect of treatment for two weeks, it is recommended to consult a doctor to clarify the diagnosis and treatment.

    If there is irritation or increased Sensitivity, treatment should be discontinued and selected by the patient another therapy.

    Any side effects of systemic SCS, including oppression of the function of the adrenal cortex, can also be noted when using local GCS, especially in children.

    Systemic absorption of local GCS may increase with prolonged use, treatment of extensive body surfaces or the use of occlusive dressings. In such cases, especially in children, appropriate precautions should be taken, including the possibility of drug cancellation, determined by the doctor depending on the severity of the disease.

    Systemic absorption of gentamicin in topical application may increase in case of application to extensive areas of the skin, especially with prolonged treatment or in the presence of skin cracks. In such cases, the development of undesirable phenomena characteristic of gentamicin in its systemic application is possible (see.section "Side effect"), therefore, careful use is recommended, especially in children, which requires the doctor to determine the frequency of application and the duration of therapy.

    Cross-allergic reactions to antibiotics from the aminoglycoside group were observed.

    With prolonged local application of gentamicin may occasionally observed growth of insensitive microflora, including fungal. In this case, as in the development irritation, hypersensitivity reactions and superinfection, treatment should be stopped and appropriate therapy prescribed.

    Cream Celestoderm®-B with Garamycin® is indicated for external use only and is not intended for use in ophthalmology.

    Effect on the ability to drive transp. cf. and fur:

    No drug effect was detected Celestoderm®-B with Garamicin® on the ability to drive and work with mechanisms.

    Form release / dosage:

    Cream for external use, 0,1% + 0,1%.

    Packaging:

    By 15 g or 30 g in an aluminum tube covered with epoxy varnish and a closing membrane and screw cap.

    One tube with instructions for use in a cardboard pack.

    Storage conditions:

    In a place inaccessible to children.

    Store at a temperature not exceeding 25 ° C.

    Shelf life:

    3 years.

    Do not use the drug after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:П N012747 / 02
    Date of registration:30.06.2011 / 15.04.2015
    The owner of the registration certificate:BAYER, AO BAYER, AO Russia
    Manufacturer: & nbsp
    Representation: & nbspBAYER, AOBAYER, AO
    Information update date: & nbsp17.11.2015
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